MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT; VENTRICULAR (ASSIST) BYPASS

Model Number	103426
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: incidental finding: wire fatigue in power cable section the reported event of damage on the patient cable was confirmed with the returned 14v power module patient cable.Visual inspection of the returned 14v power module patient cable revealed damage with visible shielding approximately 49 inches from the controller power connector end.Functional testing of the patient cable did not reveal any functional issues related to the damage.After testing, the area around the damage was removed, and visual inspection revealed the damage did not breach the shielding construction.A root cause of the damage outer insulation could not be determined through this evaluation.Device history records for 14v power module patient cable could not be located and was not reviewed.Heartmate 3 patient handbook rev d, cautions the users to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 5 ¿alarms and troubleshooting¿ describes all alarms (visual and audible) and what action should be performed when they do occur.Under section 2, ¿the system controller self test¿, the system controller self test is loud and bright.All of the lights, symbols, and sounds come on and ¿self test¿ appears on the screen.Heartmate 3 instructions for use rev c, under section f, safety checklists, replace any equipment or system component that appears damaged or worn.Heartmate ii lvas ifu rev.C (section 7), heartmate ii patient handbook rev.B (section 5), under alarms and troubleshooting, describes all alarms (visual and audible) and what action should be performed when they do occur.Heartmate ii lvas ifu rev.C, heartmate ii patient handbook rev.B, both of which cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient cable was broken and was replaced.

• Brand Name: HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17816406
• Report Number: 2916596-2023-06928
• Device Sequence Number: 2342928
• Product Code: DSQ
• UDI-Device Identifier: 00813024010784
• UDI-Public: 813024010784
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 103426
• Device Lot Number: 11019042902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown